SPECIAL NOTICE
65 -- Immunodiagnostics Testing
- Notice Date
- 7/6/2016
- Notice Type
- Special Notice
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of the Air Force, Air Force Materiel Command, AFLCMC/PZIO - WPAFB, 1940 ALLBROOK DRIVE, WRIGHT-PATTERSON AFB, Ohio, 45433-5309, United States
- ZIP Code
- 45433-5309
- Solicitation Number
- FA8601-16-R-0019
- Archive Date
- 7/28/2016
- Point of Contact
- Brigette Shepherd, Phone: 9375224597
- E-Mail Address
-
brigette.shepherd-colter@us.af.mil
(brigette.shepherd-colter@us.af.mil)
- Small Business Set-Aside
- N/A
- Description
- The United States Air Force, AFLCMC/Operational Contracting Division, Wright-Patterson AFB, Ohio 45433-5344. This is a Sole Source synopsis published for informational purposes only. This proposed action is for the procurement immune analysis kits, reagents, consumables, and support to perform diagnostic testing. The system must includes an integrated platform with automation, chemistry, and immunoassays having a single point of specimen entry that performs a list of required chemistry and Immunoassay testing. The system must also be fully automated and fully integrated to communicate with the information system that is capable of high throughput. The Government intends to solicit and negotiate with only one source under the authority of FAR 13.106 (b)(2). This proposed procurement will be a Sole Source under North American Industry Classification System Code (NAICS) 325413, In-Vitro Diagnostic Substance Manufacturing. Size standard is 1250 employees. The proposed source is Roche Diagnostics Corporation, 9115 Hague Rd, Indianapolis, In. 46256-1025. USA. This notice of intent is not a request for competitive quotations. However, all responsible sources may submit a capability statement, proposal, quotation or exception to the intent to purchase on a sole source basis, which shall be considered by the Government if received by Wednesday, 13 July 2016 by 3:00 P.M. EST of this notice and meet all the following requirements: Instrumentation and minimum requirements are the following : 1. Must provide Clinical Chemistry and Immunoassays integrated into a single platform with a single point of entry. 2. Must provide immunoassay incubation time of not more than 28 minutes.. 3. Must be capable of high through put of at least 240 tests per hour. 4. The contractor will provide enough instrumentation, reagent and consumables to complete an average daily test load within a 12-hour window. (The daily workload can be estimated from the anticipated annual workload and factoring in TUE - SAT testing, except on federal holidays). 5. Must have bidirectional computer interface that is compatible with Composite Health Care System (CHCS) 6. Must sample directly from primary patient tube or an aliquot tube. 7. Must have the capability to read sample bar codes 8. Must be able to read more than one bar code symbology 9. Must have the capability of reloading sample, reagent and supplies without interruption from sample processing 10. Must detect if primary patient sample has inadequate volume for required testing 11. Must automatically dilute patient sample if initial testing is outside the reportable range. 12. Must have automatic clot detection 13. Must have continuous specimen loading capability 14. Must have automatic test reflex capability that are programmable by the user 15. Must have auto-verification capabilities 16. Must have tiered pricing based on workload changes projected in future. Automation Minimum Requirements: 1. Must have pre-analytic de-capping of sample tube 2. Must have pre-analytic evaluation of sample integrity 3. Must have post-analytic sealing/capping of sample tube 4. Must have post-analytic aliquoting and capping of secondary tube 5. Must have sorting samples base on ordered test to analyzer 6. Must sort samples based on collection date and tube type 7. Must have pre-analytic evaluation sorted to error holding lane for review 8. Must be capable of programmable rule base interface Instrument Install and Training Support: 1. Must provide instrument transportation, delivery, and installation, to include calibration, test, and system validation support. 2. Must provide training to include onsite training and vendor specific to cover training that is not covered at onsite training. Off site training will be a minimum of two per instrument provided. The contractor will provide, all expense to include but not limited to travel, lodging, meals and any additional expense that are training specific. 3. Must provide training and support for automation rules programming. 4. Installation will use current electrical and water supplies. Instrument Repair and Maintenance: At a minimum, the contractor will provide the following maintenance and repair services: 1. Must provide onsite maintenance (monthly, quarterly, annually, etc.) in accordance with manufactures guidelines. 2. Must provide all required tools, parts and labor as necessary to keep the instrument operational. 3. Must provide over the phone, instrument technical support during normal duty hours (0730 - 2200 EST) 4. The contractor will monitor equipment to ensure instrument downtime will not exceed 48 hours for a single occurrence. 5. In the event of an instrument failure, the contractor will provide onsite technical support with a response time of <24 hours. The contractor is responsible for all tools, parts, travel/lodging and labor that are necessary to bring the instrumentation back online in <48 hours from service call. Reagent Minimum Requirements: 1. Instrument/reagent kits must be FDA approved and will provide analytical sensitivity along the entire range of the manufacturer's stated measuring range. 2. Upon request, sufficient reagents shall be provided by the vendor for in-house evaluation of each analyte. 3. Following evaluation, each test kits shall exhibit at least 95% agreement with test kits currently in use in the Immunodiagnostics Laboratory. 4. The contractor will be the sole manufacturer and distributor of the test kits. 5. The contractor will provide assistance troubleshooting any issues that result from College of American Pathologist (CAP) proficiency testing. 6. The contractor has or is pursuing HIV Ag/AB 4th Gen Combo and this test will be added for use as soon as it is available. Must be able to perform the following tests on a single point of entry platform: • Antibodies (Total) to Hepatitis A Virus • Antibodies (IgM) to Hepatitis A Virus • Antibodies (Total) to Hepatitis B Core Antigen • Antibodies (IgM) to Hepatitis B Core Antigen • Antibodies to Hepatitis B Surface Antigen • Hepatitis B Surface Antigen • Hepatitis B Surface Antigen Confirmation • Antibodies (IgG) Hepatitis C Virus • Testosterone Total • Sex Hormone Binding Globulin (SHBG) • Albumin • HgBA1C • Prostatic Specific Antigen, Free • Prostatic Specific Antigen, Total • Antibodies to Thyroglobulin • Antibodies to Thyroid Peroxidase • Antibodies to TSH Receptor • T3 • T4 • T3, Free • T4, Free • T Uptake • TSH • Immunoglobulin A • PTH, Intact • Calcium • DHEA Sulfate • C-Reactive Protein • Iron with TIBC/UIBC • BHCG • AFP • CA 125 • CA 15-3 • CA 19-9 • Cortisol • Alpha 1 Antitrypsin • C3 • C4 • Ammonia • Insulin • APO A • APO B • Ceruloplasmin • Cystatin C • Fructosamine • Haptoglobin • IgG • IgM • Lipase • Rheumatoid Factors • Transferrin • C-Peptide • Estradiol • Folate • RBC Folate • Vitamin B12 • Myoglobin • Beta 2 Microglobulin • High Sensitive C Reactive Protein • Ferritin • D-Dimer Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to comply with FAR 5.207(c)(15), the reason for lack of competition is as follows: The Government requires the Roche Diagnostics Cobas 8100/8000 (integrated c501/e602) which includes an integrated platform with automation, chemistry, and immunoassays having a single point of specimen entry that performs the required Chemistry and Immunoassay that include sixty one (61) specific tests outlined in the requirements. The Department of Defense (DoD) has determined the System for Award Management (SAM) to be the single DoD registration for contractors who conduct business or who are interested in conducting business with the DoD. Contractors must be registered in SAM prior to award for solicitations issued after 29 May 2012. You may contact SAM at 866-606-8220. SAM website: www.SAM.gov Any information should be e-mailed to brigette.shepherd-colter@us.af.mil no later 3:00 p.m. on Wednesday, 13 July 2016. Only inquiries/Information received by this date and time will be considered. Be advised that all correspondence sent via email shall contain a subject line that reads "Immunodiagnostics Testing". Note that email filters at Wright-Patterson AFB are designed to filter emails without subject lines or with suspicious subject lines or contents (i.e.,.exe, or.zip files). Therefore, if this subject line is not included, the email may not get through the email filters. Also be advised that.zip or.exe files are not allowable attachments and may be deleted by the email filters at Wright-Patterson AFB. If sending attachments with email ensure only.pdf,.doc, or.xls documents are sent. The email filter may delete any other form of attachments.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USAF/AFMC/88 CONS/FA8601-16-R-0019/listing.html)
- Place of Performance
- Address: Wright Patterson AFB. Ohio, Dayton, Ohio, 45433, United States
- Zip Code: 45433
- Zip Code: 45433
- Record
- SN04172151-W 20160708/160706234504-420e380702ebdd6bcc550e0e8e862ef5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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